China-based biopharma Hinova Pharmaceuticals has announced the enrollment of the first patient in an open, multi-center Phase II study assessing the safety, pharmacokinetics, and anti-tumor activity of its Category 1 chemical drug, HP518, in patients with metastatic castration resistant prostate cancer (mCRPC).
Innovative Mechanism of Action for HP518
HP518 is an androgen receptor (AR)-targeted PROteolysis TArgeting Chimera (PROTAC) drug, and it currently has no comparable product approved in China or internationally. By leveraging the intracellular ubiquitin proteasome system, HP518 facilitates the degradation of the androgen receptor, thereby reducing its protein expression level. This mechanism inhibits the growth of AR-dependent cancer cells, aiming to provide an effective treatment option for patients with prostate cancer.
Positive Phase I Results and Future Prospects
HP518 has successfully completed a Phase I study in mCRPC in Australia, where the results demonstrated good safety and tolerability, along with promising efficacy signals in mCRPC patients. The initiation of the Phase II study marks a significant step forward in the development of HP518, potentially paving the way for new therapeutic options in the treatment of advanced prostate cancer.-Fineline Info & Tech